MAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc.MAGNETOM Skyra Fit is a 3 Tesla MRI system by Siemens designed to produce detailed transverse, sagittal, coronal, and oblique cross-sectional magnetic resonance images and spectra of the head, body, and extremities. It assists clinicians by providing high-quality images and physical parameters helpful for diagnosis, and can also support imaging during interventional procedures.
Intended Use
The MAGNETOM system is indicated as a magnetic resonance diagnostic device that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, displaying internal structures and/or function of the head, body, or extremities to assist in diagnosis. It may also be used during interventional procedures with MR compatible devices.
Technology
MAGNETOM Skyra Fit is a 3T MRI system upgraded from MAGNETOM Verio. It includes modified hardware such as updated covers and electronic cabinets, and software features like TSE MoCo (image-based motion correction) and automatic fiducial detection for breast biopsy. It also features a Fast GRE RefScan for faster calibration and uses software syngo MR XA50A.
Performance
Performance testing included image quality assessment with sample clinical images, bench tests of new and modified hardware, software verification and validation, and complete system electrical and mechanical safety tests. The tests demonstrated equivalent safety and performance to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/1/2022
2 months - 2
FDA Approval
5/13/2022
Other devices from Siemens Medical Solutions USA, Inc.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.